BEUDAMED
    FDA Adverse Event Other Summary report: N

    GENESIS FE 500

    MDR report key: 3338714 · Received August 29, 2013

    Report

    Report Number
    3003402518-2013-00006
    Event Type
    Other
    Date Received
    August 29, 2013
    Date of Event
    January 7, 2013
    Report Date
    August 27, 2013
    Manufacturer
    TECAN SCHWEIZ AG
    Product Code
    JQW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TECAN RECEIVED EIGHT COMPLAINTS FOR THIS SPECIFIC INSTRUMENT IN 2013, AMONG WHICH THREE (NOTIFICATION NUMBERS (B)(4) DATED 04/17/2013, (B)(4) DATED 07/19/2013 AND (B)(4) DATED 07/30/2013) WERE SPECIFICALLY REFERENCING DROPPING TUBES. COMPLAINT (B)(4) WAS ONLY REFERENCING COMPLAINT (B)(4). ROOT CAUSE OF THE FIRST REPORTED COMPLAINT ((B)(4)) WAS USE OF INCORRECT TUBES (NOT FOLLOWING TECAN'S RECOMMENDATION, SEE OPERATING MEDICAL 391400 V 3.4). COMPLAINT (B)(4) REPORTED THE SAME INCIDENT, ROOT CAUSE WAS NOT IDENTIFIED. THE INSTRUMENT WAS EVALUATED BY A TECAN SERVICE ENGINEER ON 07/23/2013 AND FOUND TO BE OPERATING WITHIN SPECIFICATIONS. THE ERROR WAS NOT REPRODUCED. NO REPORTS OF CROSS CONTAMINATION OR INCORRECT RESULTS WERE REPORTED WITH THESE COMPLAINTS. THE INSTRUMENT OPERATING MANUAL 391400 V 3.4 DESCRIBES ON PAGE 6-16 TROUBLE SHOOTING TIPS TO AVOID DROPPING OF TUBES. THE DAILY MAINTENANCE PROCEDURE ALSO RECOMMENDS CLEANING OF THE GRIPPER, REFERENCED IN SECTION 7.2.2 OF THE GENESIS FE 500 OPERATING MANUAL 391400 V 3.4. AT THE CURRENT TIME TECAN CANNOT ESTIMATE IF THE INCIDENT DATED (B)(6) 2013 WAS CAUSED DUE TO USER ERROR/USE OF INCORRECT TUBES OR INSTRUMENT PERFORMANCE. HOWEVER, UP TO DATE TECAN HAS NO EVIDENCE THAT THE INSTRUMENT DID NOT WORK ACCORDING TO ITS SPECIFICATIONS. AT THIS TIME POINT NO FURTHER CORRECTIVE ACTION IS PLANNED. TECAN IS IN CONTACT WITH THE CUSTOMER TO FURTHER EVALUATE THE INCIDENT DATED (B)(6) 2013. WHEN ADDITIONAL INFO IS AVAILABLE WE WILL AMEND THIS REPORT. TECAN WAS NOTIFIED ON 08/27/2013 THAT (B)(6) CLOSED THIS REPORT.

    Description of Event or Problem · 1

    MEDICAL DEVICE INCIDENT NOTIFIED ON 07/15/2013 BY CUSTOMER (B)(6) INFIRMARY ((B)(6)) TO (B)(6) IN OF WRONG RESULTS REPORTED FOLLOWING CONTAMINATION OF THE PT SAMPLE WITH SERUM FROM A DROPPED SPECIMEN. INCIDENT HAPPENED ON (B)(6) 2013, WHILE PROCESSING SAMPLES USING A FE 500 INSTRUMENT. NATURE OF THE INJURY WAS NOTED AS DISTRESS. (B)(6) CONTACTED TECAN ON 07/31/2013 TO GET MORE INFO ABOUT THE INCIDENT. TECAN WAS NOT NOTIFIED BY CUSTOMER OF THIS WRONG RESULT OF THE COMPLAINT INCIDENT AND WAS ONLY AWARE OF IT ONCE RECEIVING THE REQUEST FROM (B)(6). AN INVESTIGATION WAS OPEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425413 GENESIS FE 500 PIPETTING STATION FOR CLINICAL USE JQW TECAN SCHWEIZ AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Other